Indocyanine Green Imaging for Bariatric Surgery

Overseen By Priya Sharma

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Substance abuse, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special dye, indocyanine green (ICG), to help surgeons visualize blood flow during Roux-en-Y gastric bypass surgery. The aim is to determine if using this dye during surgery can reduce complications such as ulcers and leaks. Suitable participants have been approved for this surgery and are committed to follow-up care, including diet and lifestyle changes. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take PPI medication (a type of drug that reduces stomach acid) after the surgery.

What is the safety track record for Indocyanine Green?

Research has shown that indocyanine green (ICG) is safe for use in weight-loss surgery, with complications from the dye being very rare. ICG enhances surgeons' ability to see blood flow during surgery, increasing the operation's safety. One study found that using ICG led to shorter surgeries and reduced blood loss. These findings suggest that patients tolerate ICG well. Therefore, for those considering joining a clinical trial with ICG, current evidence supports its safety in similar surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Indocyanine Green (ICG) is unique because it enhances visualization during bariatric surgery by providing real-time imaging of blood flow and tissue perfusion. Unlike standard techniques that rely on the surgeon's eye alone or indirect imaging methods, ICG offers a direct, dynamic view, potentially improving surgical precision and outcomes. Researchers are excited about this treatment as it could lead to fewer complications and better recovery times by allowing for more accurate assessment of the surgical area.

What evidence suggests that Indocyanine Green is effective for assessing blood flow during bariatric surgery?

Research shows that indocyanine green (ICG) aids in weight-loss surgery by checking blood flow. Good blood flow is crucial for preventing problems like leaks or ulcers after surgery. Some studies found that ICG helped surgeons see the blood supply more clearly, potentially avoiding issues during surgery. Although no strong proof yet links ICG directly to reduced complications, it remains safe and useful for surgeons. In this trial, participants in the interventional group will receive ICG during bariatric surgery to assess its potential in managing and preventing complications. ^{1 3 6 7 8}

Who Is on the Research Team?

Allan Okrainec

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are eligible for Roux-en-Y gastric bypass (RYGB) surgery in Ontario and can commit to the bariatric program's follow-up, including lifestyle changes. They must be able to consent and may have had treatment for a marginal ulcer. It excludes those with allergies to indocyanine green or Sodium Iodide, substance abuse/smoking issues, unwillingness to take PPIs post-op, pregnancy plans within two years, or bleeding/coagulation disorders.

Inclusion Criteria

I am committed to following the bariatric program's guidelines for diet and behavior changes.

I understand and can agree to the study's procedures and risks.

I am over 18 years old.

Exclusion Criteria

Known allergy to indocyanine green or Sodium Iodide

Is participant pregnant or planning to get pregnant in next two years

I have a bleeding disorder or a problem with blood clotting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

ICG imaging is performed intraoperatively to assess blood flow during Roux-en-Y gastric bypass surgery

1 day

1 visit (in-person, surgery)

Follow-up

Participants are monitored for complications such as marginal ulcerations, leaks, and strictures

2 years

Standard bariatric follow-up visits

Mid-term analysis

Mid-term analysis of procedure and patient outcomes for quality assurance

When half the study patients have undergone intraoperative ICG use

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview

The study tests if using the Stryker 1688 AIM system along with Indocyanine Green dye helps surgeons see blood flow during RYGB surgery better. The goal is to check if this method reduces complications like ulcers, leaks, and strictures after surgery.

How Is the Trial Designed?

Group I: Interventional group (with drug) Experimental Treatment 2 Interventions

The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Stryker Endoscopy

Industry Sponsor

Trials

5

Recruited

2,000+

Published Research Related to This Trial

In a study involving 1226 patients and 1923 ICG videoangiography tests, the safety of intravenous indocyanine green (ICG) was confirmed, with only 0.15% experiencing mild adverse reactions and 0.2% moderate reactions.

The study found one severe adverse reaction (0.05%) but no fatalities, highlighting the high level of safety associated with ICG in ophthalmic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions due to indocyanine green. Hope-Ross, M., Yannuzzi, LA., Gragoudas, ES., et al.[2022]

Indocyanine green (ICG) is a useful fluorescent dye in bariatric surgery that can help assess tissue perfusion and perform leak testing, potentially leading to intraoperative decision changes in 3.8% of cases.

The study highlights the need for further research to confirm the routine use of ICG in both standard and complex bariatric surgical procedures, indicating its promise in reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green in Bariatric Surgery: a Systematic Review. Hsu, A., Mu, SZ., James, A., et al.[2023]

In a pilot study involving 13 bariatric surgery patients, the use of indocyanine green (ICG) fluorescence angiography (FA) was found to be safe and effective, with no adverse effects reported and 84.6% of patients showing excellent vascularization scores.

The ICG-FA helped identify vascular supply issues in two patients, leading to changes in surgical strategy, and importantly, no postoperative leaks occurred during a median follow-up of five months, suggesting its potential to reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescence Angiography During Laparoscopic Bariatric Surgery: A Pilot Study. Balla, A., Corallino, D., Quaresima, S., et al.[2022]

In a study involving 40 bariatric surgery patients, the use of quantitative indocyanine green fluorescence angiography (ICG-FA) showed no adverse events and effectively assessed blood supply during surgery.

Importantly, there were no post-operative leaks detected in any of the patients, suggesting that ICG-FA could be a valuable tool for preventing complications in bariatric surgery, although more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of quantitative indocyanine green near-infrared fluorescence imaging in bariatric surgery: early results. Biancucci, A., Fassari, A., Lucchese, S., et al.[2023]

In a study of 30 patients undergoing laparoscopic Roux-en-Y Gastric Bypass, indocyanine green (ICG) fluorescence angiography effectively demonstrated adequate blood supply to the stomach and gastro-jejunal anastomosis during surgery.

Despite showing good perfusion with ICG, the methylene blue test indicated potential risks for leakage, suggesting that while ICG can help assess vascularity, other factors also contribute to the risk of gastric fistula formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study. Pavone, G., Fersini, A., Pacilli, M., et al.[2022]

In a study of 43 patients undergoing laparoscopic sleeve gastrectomy, the use of indocyanine green (ICG) for assessing blood supply showed no adverse events, indicating its safety in this context.

Despite satisfactory blood supply assessments along the stapled line in all cases, one patient experienced a gastric leak post-surgery, suggesting that blood supply alone may not predict leak risk, highlighting the need for further investigation into other contributing factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescent Angiography During Laparoscopic Sleeve Gastrectomy: Preliminary Results. Di Furia, M., Romano, L., Salvatorelli, A., et al.[2021]

In a study of 266 patients with gastric cancer, the use of indocyanine green (ICG) imaging during laparoscopic D2 lymphadenectomy significantly increased the number of lymph nodes retrieved compared to conventional methods, with an average of 50.5 lymph nodes in the ICG group versus 42.0 in the non-ICG group.

The ICG group also had a lower rate of lymph node noncompliance (31.8%) compared to the non-ICG group (57.4%), while the postoperative recovery and complication rates were similar between both groups, indicating that ICG imaging is safe and effective for enhancing lymphatic mapping in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. Chen, QY., Xie, JW., Zhong, Q., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12329663/

Safety of indocyanine green use in bariatric and metabolic ...

CONCLUSIONS. The use of intraoperative ICG in metabolic and bariatric surgery is safe, and adverse events and dye-related complications are very rare.

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journalofgastricsurgery.com

journalofgastricsurgery.com/index.php/JGS/article/view/47

The use of indocyanine green in bariatric surgery

Currently no evidence suggests that its use can reduce postoperative complications in bariatric surgery. We think that ICG use may be a valuable aid to the ...

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nature.com

nature.com/articles/s41598-023-36442-4

Assessment of gastric pouch blood supply with ...

Our study aimed to evaluate the usefulness of indocyanine green (ICG) angiography during conversional or revisional bariatric surgery.

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journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/15533506251339931

Clinical Role of ICG Application in Bariatric Surgery

ICG is a promising technique for successfully preventing or timely managing AL in bariatric surgery. Large, randomised controlled studies are ...

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frontiersin.org

frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.906133/full

Indocyanine Green Fluorescence Angiography During ...

Results: Fom January 2021 to February 2022, six patients underwent LSG (46.2%), three patients underwent LGB (23.1%), and four patients ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40785745/

Safety of indocyanine green use in bariatric and metabolic ...

The use of intraoperative ICG in metabolic and bariatric surgery is safe, and adverse events and dye-related complications are very rare.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1091255X23019133

The Feasibility and Safety of Preoperative Fluorescence ...

The ICG group had shorter procedure time (p < 0.001), lower estimated blood loss (p = 0.005), and significantly shorter postoperative hospital stay (p < 0.001).

8.

journalofgastricsurgery.com

journalofgastricsurgery.com/index.php/JGS/article/download/47/95/611

The use of indocyanine green in bariatric surgery

[1] Surgery for obesity is also recognized as a safe treatment, with mortality rates comparable to those of other common procedures (e.g., appendectomy,.